Trial Outcomes & Findings for Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study (NCT NCT01968135)
NCT ID: NCT01968135
Last Updated: 2016-05-05
Results Overview
Proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of the 14-day treatment period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
At day 3 of 14 day course of study drug
Results posted on
2016-05-05
Participant Flow
Women were invited to participate after being seen at one of our institution's clinics with the complaint of bothersome bleeding during use of etonogestrel implant, or after responding to advertisements posted on the internet, in the local newspaper, or around public venues. Women were enrolled and followed from November 2013 - December 2014.
Interested women were screened by phone and subsequently invited for a screening visit. At this visit they were assessed for eligibility based on the specified inclusion/exclusion criteria.
Participant milestones
| Measure |
Sugar Pill
Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill
|
Combined Oral Contraceptive Pill
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=16 Participants
Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill
|
Combined Oral Contraceptive Pill
n=16 Participants
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.4 years
STANDARD_DEVIATION 4.8 • n=93 Participants
|
21.4 years
STANDARD_DEVIATION 3 • n=4 Participants
|
21.9 years
STANDARD_DEVIATION 4.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
16 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
BMI
|
23.2 kg/m^2
STANDARD_DEVIATION 2.9 • n=93 Participants
|
23.3 kg/m^2
STANDARD_DEVIATION 3.5 • n=4 Participants
|
23.2 kg/m^2
STANDARD_DEVIATION 3.2 • n=27 Participants
|
|
Total days of current bleeding episode
|
49.6 days
STANDARD_DEVIATION 44.6 • n=93 Participants
|
30.3 days
STANDARD_DEVIATION 37.7 • n=4 Participants
|
39.9 days
STANDARD_DEVIATION 41.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: At day 3 of 14 day course of study drugProportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of the 14-day treatment period.
Outcome measures
| Measure |
Sugar Pill
n=16 Participants
Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill
|
Combined Oral Contraceptive Pill
n=16 Participants
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
|
|---|---|---|
|
Cessation of Vaginal Bleeding
|
37.5 percentage of participants
|
87.5 percentage of participants
|
SECONDARY outcome
Timeframe: over the 14 day course of study drugOutcome measures
| Measure |
Sugar Pill
n=16 Participants
Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill
|
Combined Oral Contraceptive Pill
n=16 Participants
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
|
|---|---|---|
|
Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred
|
9 days
Interval 5.0 to 14.0
|
5 days
Interval 1.0 to 13.0
|
SECONDARY outcome
Timeframe: Over the 14 day course of study drugOutcome measures
| Measure |
Sugar Pill
n=16 Participants
Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill
|
Combined Oral Contraceptive Pill
n=16 Participants
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
|
|---|---|---|
|
Number of Days Without Bleeding During Therapy
|
3.5 days
Interval 0.0 to 11.0
|
9 days
Interval 1.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to six monthsOutcome measures
| Measure |
Sugar Pill
n=16 Participants
Placebo Sugar Pill
Placebo Sugar Pill: Placebo Sugar Pill
|
Combined Oral Contraceptive Pill
n=16 Participants
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
|
|---|---|---|
|
Number of Days to Recurrence of Bleeding After Discontinuation of Therapy
|
10 days
Interval 3.0 to 87.0
|
5.5 days
Interval 1.0 to 131.0
|
Adverse Events
Sugar Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined Oral Contraceptive Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place